ESD AqaNife 200.53.04

GUDID 04260206310419

The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes • precise marking of tissue • stable position of the needle • ceramic socket as stopper and protector • opening in the ceramic socket for flushing and re-injection • for thick tissue (needle length of 3.0 mm)

Ovesco Endoscopy AG

Endoscopic electrosurgical electrode, monopolar, single-use

Primary Device ID	04260206310419
NIH Device Record Key	8ddf53ea-3959-4478-bad2-7f8cf9e91a3a
Commercial Distribution Discontinuation	2018-11-26
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	ESD AqaNife
Version Model Number	3.0 mm
Catalog Number	200.53.04
Company DUNS	344007369
Company Name	Ovesco Endoscopy AG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+19196519449
Email	customerservice@ovesco-usa.com
Phone	+19196519449
Email	customerservice@ovesco-usa.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260206310419 [Previous]
GS1	04260206311065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K141790

FDA Product Code

GEI	Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-10-31
Device Publish Date	2016-09-16

On-Brand Devices [ESD AqaNife]

04260206310419	The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes
04260206310402	The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes
04260206310396	The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes
04260206310389	The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes